comparison_of_herbal_pharmacopoeiaa.pptx

Note on Quality control of herbal..8th sem

1. Comparison of various herbal pharmacopoeias Quality control & standardization of herbals

2. Comparison of various herbal pharmacopeias Herbal Pharmacopoeia is a, reference book for the preparation of quality medicines, published by the authority of a Government and represents qualitative and therapeutic monographs on botanicals.
Herbal Pharmacopoeia is a compiled document which: (a) Defines botanical drug.
(b) Provides information for its proper identification.
(c) Contains the basic description including; nomenclature, plant parts used, active constituents, range of application, contraindications and side effects, incompatibilities with other medications, dosage, use and action of the herb.
It is an important reference for all individuals and organizations working within Pharmaceutical research and development, manufacture and testing around the globe.
The modern-day pharmacopoeias are strictly for standards of medicines and every developed country has a pharmacopeia for their medicaments of synthetic as well as natural origin.

3. PHARMACOPOEIA American Herbal Pharmacopoeia (AHP) African Herbal Pharmacopoeia ( AfrHP ) British Herbal Pharmacopoeia (BHP) Korean Herbal Pharmacopoeia (KHP) Pharmacopoeia of the People's Republic of China ( ChP ) The Turkish Pharmacopoeia (TP) Pharmacopoeia Argentina Brazilian Pharmacopoeia Indian Herbal Pharmacopoeia

4. American Herbal Pharmacopoeia (AHP) The primary goal of the AHP is to produce authoritative herbal monographs containing accurate, critically reviewed information on botanicals which can provide guidance in the appropriate use of herbal therapeutics. The American Herbal Pharmacopoeia began developing qualitative and therapeutic monographs in 1994, and intends to produce 300 monographs on botanicals, including many of the Ayurvedic, Chinese and Western herbs. These monographs represent the most comprehensive and critically reviewed body of information on herbal medicines in the English language and serve as a primary reference for academicians, health care providers, manufacturers and regulators. The AHP monographs are combined monographs; they include much of the standard definitional and analytical information found in conventional pharmacopeial monographs on standards, plus therapeutic and clinical information.

5. EXAMPLES OF PLANTS CONTENT OF MONOGRAPHS Ashwagandha root Astragalus root Bilberry fruit Black cohosh rhizomes Chaste tree fruit Cramp bark Valerian root Ginko leaf Echinacea purpurea root Definition /Title Synonym Vernacular names Description Plant material of interest Geographical distribution Commercial use Identity tests Assay Chemical Constituents Medicinal Values Pharmacology Contraindications Warning Precaution ADR Dose References

6. African Herbal Pharmacopoeia (AfrHP) Published in 2010 by Association of African medicinal Standards. The AfrHP provides comprehensive, up to date botanical, commercial and phytochemical information on over 50 of the most important African medicinal plants. The technical data were made on plant samples sourced from across the continent. These monographs were prepared by leading African scientists and have been reviewed by international experts. Additional data includes; micro-morphology of the plant material, distribution. maps and TLC chromatograms. These data are crucial for producers, collectors and traders in medicinal plants and extracts as well as researchers, manufacturers and practitioners. The scope, quality and standard of these herbal monographs are comparable to those prepared in Europe, North America and Asia.

7. British Herbal Pharmacopoeia (BHP) The UK founded British Herbal Medical Association (BHMA)in 1964 to, advance the, science and practice of herbal medicines in order to ensure its statutory recognition. First British Herbal Pharmacopoeia (BHP) was published by BHMA in 1971/1983 giving monographs and quality control tests for some of the common herbs and herbal products in the UK, Revised in 1990 -84 monographs. 1996-169 monographs. The BHP monograph includes a brief description of the form of the material, its main geographical sources, macroscopical and microscopical descriptions of the herbal material, prepared by eminent pharmacognosists, together with odour and taste descriptions.

8. it also includes; comparative identification and qualitative phytochemical analysis. However, the BHP remains a very useful aid to quality assurance, particularly for herbs not featured in official pharmacopoeias. In1992 BHMA published a companion British Herbal Compendium, Volume 1 which gives therapeutic monographs on the same 84 herbs. BHP mainly paid attention on developing TLC techniques for comparative identification of new botanical drugs.

9. The British Herbal Pharmacopoeia (BHP) has several key features: Quality Standards: The BHP provides detailed quality standards for herbal raw materials. These standards ensure, consistency and safety in herbal medicine production. Monographs: It includes monographs for 169 herbal substances, covering their botanical characteristics, preparation methods and therapeutic uses. Dosage Guidelines: The BHP offers dosage recommendations for each herb, helping practitioners determine appropriate amounts for therapeutic purposes. Safety information: Safety considerations, contraindications, and potential interactions are outlined to guide practitioners and users. Traditional Knowledge: The BHP acknowledges traditional uses and historical context for each herb.

10. PLANT EXAMPLES Aniseed Asafoetida Birch leaf Catechu Cayanne pepper Cehery seed Clove Devil Clove Aloe Garlic CONTENT OF MONOGRAPH 1 Definition 8 Geographical distribution 2 Synonym 9 assay 3 Vernacular name 10 Chemical constituents 4 Characteristics 11 Mode of action 5 History 12 storage 6 Description 7 Plant material of interest

11. THE KOREAN HERBAL PHARMACOPOEIA A reference book for the preparation of quality herbal medicines. It was first published in 1984 by the Ministry of Health & Welfare in South Korea with 387 monographs. The latest one 12 th (2019) contains a total of 2,462 official monographs (Part I and Part II). Part I includes; frequently used drugs and their primary preparations and Part II includes; crude drugs, biological drugs, radioactive drugs, combined preparations, additives for preparations and quasi-drugs. The Pharmacopoeia comprises the following items, in order, general notices, general requirements for preparations, monographs, general tests, processes and apparatus and general information followed by the index. The KHP is an essential resource for pharmaceutical research, development, and testing globally. It plays a crucial role in ensuring the quality and safety of herbal medicines in South Korea.

12. These monographs provide the following information on botanical drugs, Name in latin Name in Korean Definition Content rule Manufacturing Description Identification Purity test loss on drying Moisture content Ash Acid insoluble ash Oil content Extract content Quantitative assay Storage Processing Grade including proper identification, nomenclature, plant parts used, active constituents, contraindications, side effects, and dosage

13. THE PHARMACOPOEIA OF THE PEOPLE’S REPUBLIC OF CHINA (PPRC)/ CHINESE PHARMACOPOEIA Compiled by the Pharmacopoeia Commission of the Ministry of Health of the People's Republic of China in 1953- It contains 531 monographs both Traditional Chinese and Western medicines. Under the umbrella of the China Food and Drug Administration (CFDA), the Chinese Pharmacopoeia Commission ( ChPC ) and its stakeholders (drug control institutions, research institutions, universities and drug manufacturers) prepared the Chinese Pharmacopoeia in line with the basic principles, goals and requirements of the era. The Chinese Pharmacopoeia includes; monographs s of vegetables, oil, fats and extracts, medicinal materials and the prepared slices of Chinese crude drugs, single item preparations, chemical drugs, antibiotics, biochemical and radioactive drugs, pharmaceutical excipients and biologicals. General chapters include; general requirements sof preparations, testing methods, standard substances, reagents and the guidelines. The ChP provides information on the standards of purity, description, tests, dosage, precautions, storage, and strength for each DRUG.

14. CHINESE PHARMACOPOEIA Editions 1953 - I Edition 1963 - II Edition 1977 - III Edition 1985 - IV Edition 1990 - V Edition 1995 - VI Edition 2000 - VIIEdition 2005 - VIII Edition 2010 - IX Edition 2015 - X Edition 2020 - Latest Edition Volume Content Number Volume I Traditional Chinese medicine monographs 2,711 Volume II Chemical drug ( including chemical APIs, also known as active pharmaceutical ingredients) monographs. 2,712 Volume III Biological product monographs 153 Volume IV General chapters General requirements for preparation 38 Testing methods and others requirements 281 Guidelines 42 Pharmaceutical excipients monographs 335 2020 EDITION IV Volumes – 5911 Monographs with 319 new additions Translated into English & officially published by Chinese pharmacopoeia commission on March 14 2023

15. • Turkish Pharmacopoeia includes European Pharmacopoeia monographs as well as national monographs. It has a section containing herbal, biological or biotechnological products and finished products. They are first published in the Turkish Pharmacopoeia Journal and then in the Turkish Pharmacopoeia and become official. The first edition published in 1930& include 659 monographs. Updated in 1940, 1948, 1954, 1974, 2004, 2016&2017. In the latest version, the number of national monographs has reached 32 and most of them are monographs sof medicinal and aromatic herbal ingredients. The Turkish Pharmacopoeia-II Monographs (Europe Pharmacopoeia Adaptation) was published in 2016. It consists of three volumes and provides essential guidelines for pharmaceutical quality and safety

16. Turkish Pharmacopoeia Turkish Pharmacopoeia includes European Pharmacopoeia monographs as well as national monographs. It has a section containing herbal, biological or biotechnological products and finished products. They are first published in the Turkish Pharmacopoeia Journal and then in the Turkish Pharmacopoeia and become official. The first edition published in 1930 & include 659 monographs. Updated in 1940, 1948, 1954, 1974, 2004, 2016 & 2017. In the latest version, the number of national monographs has reached 32 and most of them are monographs of medicinal and aromatic herbal ingredients. The Turkish Pharmacopoeia- 2 Monographs (Europe Pharmacopoeia Adaptation) was published in 2016. It consists of three volumes and provides essential guidelines for pharmaceutical quality and safety.

17. Pharmacopoeia Argentina Pharmacopoeia Argentina is published by The National Administration of Medicines Food and Medical Technology and it is in the Spanish language. Pharmacopoeia Argentina provides a specification for biological, herbal products, medical products, blood products, radiopharmaceutical products, for vaccines and includes general monographs and supplementary texts.

18. Brazilian pharmacopoeia Published by Pharmacopoeia Coordination Brazilian Health Surveillance Agency in three different languages; Portuguese, English and Spanish. Apart from Brazilian Pharmacopoeia, Herbal Medicines National Formulary (Portuguese/ Spanish) and Herbal Medicines Memento (Portuguese) are also used in Brazil. Brazilian Pharmacopoeia provides specifications via monographs for APIs and excipients, for dosage forms, for biological, for herbal products and includes monographs for medical devices.

19. INDIAN HERBAL PHARMACOPOEIA The Indian Pharmacopoeia (IP) is an official document published by the Indian Pharmacopoeia Commission. It aims to improve the quality of medicines by adding new and updating existing monographs. These monographs provide standards for various drugs, including herbs and herbal products. It has 40 monographs published by the Indian Drugs Manufacturers Association (IDMA) in collaboration with Regional Research Laboratory (RRL), Jammu. Index of pharmacopoeias published by the World Health Association, Geneva has a comprehensive list of pharmacopoeias of different countries.

20. AYURVEDIC PHARMACOPOEIA OF INDIA It is the legal document of standards for the quality of Ayurvedic drugs and the substance include therein. ( Under the Drug & Cosmetic act, 1940). API came in existence in 1962. It was published in 1989. API has worked out monographs on the basis of genuine and authentic drug samples approved by the physician, manufacturing experts, and other expertise on the subject. At present about 1000 single drugs and 8000 compound formulations are used in Ayurveda system including drugs of plants, animal and mineral origin in both single and compound formulation.

21. Ayurvedic Pharmacopoeia of India (API) | has monographs of 600 plants/animals/minerals and derived drugs (Part 1. Volume 1 to 8). Monographs of 152 compound Ayurvedic formulations are published in Ayurvedic Pharmacopoeia of India (Part II, Volume 1 to 3). Additionally, the Ayurvedic Pharmacopoeia of India (API) sets standards for single drugs and compound Ayurvedic formulations.

22. Volume No. of monographs Year 1 80 1986 2 78 1999 3 100 2001 4 68 2004 5 84 2006 6 101 2008 7 21 2008 8 60 2010 Part 1 Part 2: Vol 1 Vol 2 Deals with formulation These all monographs deals with the pharmacognostical , chemical and ayurvedic standards of the plant drugs which are used in Ayurveda

23. API MONOGRAPH Monograph title-Sanskrit Introductory para Synonym-English and Urdu Description Identity, Purity and Strength Physico -chemical parameters-TLC etc Properties of action Important formulation and therapeutic uses Doses-metric system For compound formulations - Method of preparations - Storage - Physicochemical parameters

24. UNANI PHARMACOPOEIA It is a form of traditional medicine widely practised in south Asia. Unani medicine is based on the concept of -4-Humors- Phlegem,blood,yellow bile and black bile. Unani Pharmacopoeia constituted in 1965 S.NO VOLUME MONOGRAPH 1 I 45 2 II 50 3 III 53 4 IV 50 5 V 52

25. FORMAT OF MONOGRAPH Monograph titles Introductory para-Botanical name and geographical locations Other names-Regional name Description Macroscopy Microscopy Powder Characteristic Identity, purity and Strength-TLC Chemical constituents Temperament like-Hot, moist, cold, dry etc. Actions-Cardiac activity(MUQAWWI-EQALB) Therapeutic uses Doses

26. SIDDHA PHARMACOPOEIA This system of medicine was developed by sages of south india to serve humanity. SPI established by government of India, under APC in 1964 under chairmanship Dr.C.S.Uthamarayan . SPI of india Part- I,Vol -I was printed in June-2008. SPI available in 2 volumes, volume I contains 73 single drug monograph and volume II is under progress. FORMAT OF SPI MONOGRAPH Monograph Titles Introduction Synonyms Descriptions Assay Constituents Properties and Action Important Formulation Therapeutic Use Dose

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